This disclosure concerns a method for quality evaluation of a handheld analytical device, specifically a blood glucose meter, wherein the device is operable by a human user in a sequence of handling steps to test an analyte in a sample fluid applied on a test element. This disclosure further concerns a system for quality evaluation of such a handheld or hand-operated analytical device.
A typical operation of a handheld blood glucose meter may include a sequence of handling steps like producing a blood sample by lancing a body part, applying the blood sample onto a disposable test element and measuring the test element in the handheld meter in order to obtain a measurement result on the spot. Such analytical devices are usually operated by patients under various conditions and state of health. Then, the inherent problem exists that a lot of individual variations may influence the reproducibility of the diagnostic test, which make it difficult to investigate and identify possible influencing parameters on the quality of the device. For example, when handheld blood glucose monitoring devices are used, variations may arise from “human factors” such as timing when applying the sample, force exertion, impurities on the skin and so on.